Duns Number:199354556
Device Description: Universal Resin Cement with Cleanup Indicator. Syringes, 4:1 Automix Tips (Regular, Wide) Universal Resin Cement with Cleanup Indicator. Syringes, 4:1 Automix Tips (Regular, Wide) and Intraoral Tips
Catalog Number
-
Brand Name
Maxcem Elite Chroma
Version/Model Number
36301
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
EMA
Product Code Name
Cement, Dental
Public Device Record Key
2c8f6947-2cff-4cbb-b0b6-21e9dcf1982f
Public Version Date
March 18, 2021
Public Version Number
2
DI Record Publish Date
May 26, 2020
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 98 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 595 |
| U | Unclassified | 5 |